临床实践中的奥帕他替:轴性脊柱关节炎治疗的新视野

T. Shivacheva, Z. Dimova, D. Simeonova, Svetoslav Dimitrov, Tsvetoslav Georgiev, Simona Bogdanova, R. Moraliyska, Svetlana Hristova, Georgi Gerganov
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引用次数: 0

摘要

简介轴性脊柱关节炎(axSpA)是一种影响轴性骨骼的炎症性疾病,伴有疼痛、活动受限等症状。强直性脊柱炎疾病活动度评分(ASDAS)是表达疾病活动度、评估炎症和症状的指标。在临床试验中,Upadacitinib 已证明可降低 axSpA 的活动性,但实际证据仍然有限。研究目的本研究旨在通过分析乌达替尼在实际临床实践中对症状、活动性和炎症指标的影响,评估乌达替尼对 axSpA 的治疗效果。其他目标还包括比较无生物制剂治疗经验和有生物制剂治疗经验患者的疗效,以及评估放射学分期对奥帕他替尼治疗反应的影响。研究方法64例 axSpA 患者接受了乌达替尼治疗。其中,42人在治疗6个月后接受评估,13人在治疗12个月后接受评估。在不同的时间点对ASDAS进行评估,并根据之前使用生物药物的经验和骶髂关节炎的影像学分期进行分析。结果。奥帕他替尼治疗6个月后,ASDAS平均值明显降低(3.5 vs. 1.9,p < 0.001),12个月后继续降低(1.6 vs. 1.9,p > 0.05)。相当一部分患者(80.9%)在 6 个月后的 ASDAS 值低于 2.1,这一结果在 12 个月后得以保持(84.6%,p > 0.05)。未使用生物制剂和有生物制剂经验的患者亚组之间没有发现明显差异(84.2% vs. 78.3%,p > 0.05)。在对其他参数(如 BASDAI、疲劳、疼痛、CRP、血红蛋白和 ESR)的分析中也观察到类似的趋势。在6个月和12个月后,无论放射学分期如何,乌达替尼都增加了低疾病活动度患者的数量(23.7%对83.3%,5.7%对85.3%,p <0.001)。结论事实证明,乌达替尼对axSpA治疗有效。无论人口学、临床和影像学疾病特征如何,也无论 "生物无效/生物失败 "状态如何,奥帕他替尼都能在治疗 6 个月和 12 个月后改善 ASDAS。在实际临床实践中,这种药物是控制 axSpA 活动的有效工具。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Upadacitinib in real clinical practice: new horizons in the treatment of axial spondyloarthritis
Introduction. Axial spondyloarthritis (axSpA) is an inflammatory disorder affecting the axial skeleton, accompanied by pain, restricted mobility, and other symptoms. The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a metric expressing disease activity, assessing inflammation and symptoms. In clinical trials, Upadacitinib has demonstrated reduced axSpA activity, but real-world evidence remains limited. Objective. The objective of this study is to evaluate the therapeutic effectiveness of Upadacitinib in axSpA by analysing its impact on symptoms, activity, and inflammatory markers in real clinical practice. Additional goals include comparing outcomes between biologic-naive and biologic-experienced patients, as well as assessing the influence of radiographic stage on Upadacitinib's therapeutic response. Methods. Sixty-four patients with axSpA were enrolled in Upadacitinib treatment. Among them, 42 were evaluated after 6 months and 13 after 12 months of therapy. ASDAS was assessed at various time points and analyzed based on prior experience with biologic drugs and radiographic stage of sacroiliitis. Results. A notable reduction in mean ASDAS values was observed after 6 months of Upadacitinib treatment (3.5 vs. 1.9, p < 0.001), with this reduction being sustained after 12 months (1.6 vs. 1.9, p > 0.05). A substantial proportion of patients (80.9%) achieved ASDAS values below 2.1 after 6 months, and this achievement was maintained after 12 months (84.6%, p > 0.05). No significant differences were found between biologic-naive and biologic-experienced patient subgroups (84.2% vs. 78.3%, p > 0.05). Similar trends were observed in the analysis of other parameters such as BASDAI, fatigue, pain, CRP, haemoglobin, and ESR. Upadacitinib increased the number of patients with low disease activity regardless of radiographic stage after 6 and 12 months (23.7 vs. 83.3% and 5.7 vs. 85.3%, p < 0.001). Conclusion. Upadacitinib proves to be effective in axSpA treatment. Regardless of demographic, clinical, and radiographic disease characteristics, as well as "biologic-naive/biofailure" status, Upadacitinib leads to ASDAS improvement after 6 and 12 months of treatment. This medication represents an effective tool in real-world clinical practice for controlling axSpA activity.
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